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Clinical Trials Team

Neurological Surgery Clinical Research Team

This team is responsible for the coordination and management of clinical trials. Activities include study-start-up, site-initiation, enrollment and follow-up, and study close-out. This team maintains the department's IRB portfolio and engages with UC Davis Health clinicians, advanced practice providers, industry sponsors, contract research organizations and ancillary services and departments to successfully support and execute trials. Clinical Research Coordinators coordinate both observational and interventional (device and drug) studies and support research activities in the inpatient hospital setting and outpatient clinics.

PENS study

Placebo-Controlled Efficacy in iNPH Shunting (PENS) is a trial interested in assessing effectiveness of surgical cerebrospinal fluid shunting for iNPH treatment.

Learn more here
Dr. Kim at the surgical microscope

Demonstrated Results

Participation in clinical trials helps our clinician scientists find results that improve lives. Dr. Kee D. Kim, Co-Director of the UC Davis Spine Center, released study results in 2022 that patients treated with neuro-spinal scaffold regained some feeling in paralyzed areas in the Journal of Neurosurgery Spine.


Clinical research the Department of Neurological Surgery faculty is conducting:

Dr. Bloch

Orin Bloch, M.D.
Professor
Neurological Surgery

  1.  Stereotactic radiosurgery and peripheral immune system activation in patients with brain mestastases from non-small cell lung cancer
  2.  Longitudinal immune profiling of patients with Glioblastoma  
  3.  Flourescence lifetime technique for detection of radiation necrosis vs glioma
David Brandman

David Brandman, M.D., Ph.D.
Assistant Professor
Neurological Surgery

  1. This is a retrospective review of the DBS program here at UC Davis.
    Project Title: [1899144-1] Demographic and Clinical Variables of DBS Candidates
    Principal Investigator: David Brandman, M.D., Ph.D.
  2. This is a sponsor-initiated clinical trial (Dr. Leigh Hochberg) based out of Mass General / Brigham Hospital. I am the site-PI of this clinical trial at UC Davis. BrainGate2 is investigating the safety of chronically implanted electrodes in people living with tetraplegia. The BrainGate neural interface reads signals from the brain and decodes them in real-time, allowing the user to control objects in their environment.
    Project Title: [1843264-1] Feasibility of the BrainGate2 Neural Interface System in Persons with Tetraplegia
    Principal Investigator: David Brandman, M.D., Ph.D.
Branden Cord

Branden Cord, M.D., Ph.D.

Assistant Professor

Neurological Surgery

  1. Feasibility Study of the treatment of Acute Ischemic Stroke using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy (the NITE1 study) SRM–2019-01
Kee Kim
Kee Kim, M.D.
Professor and Co-Director, Spine Center

Neurological Surgery

  1. ASPIRE - An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion with Instrumentation
  2. Abbvie M16-077 - A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury
  3. The Role Of Cervical Spinal Stenosis In The Production Of Cervicogenic Headache
  4. Multifactorial analysis of admission and outcomes of spine trauma
  5. Randomized, Controlled, Single-blind Study of Probable Benefit of the Neuro-Spinal Scaffold™for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care
  6. A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft with Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of MultiLevel Degenerative Lumbosacral Spinal Conditions
  7. A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures
  8. The INSPIRE Study: InVivo Study of Probable Benefit for the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury
  9. A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis with Spinal StenosisEmpirical Spine
  10. A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects with Lumbar Disc Herniation (Phase 3)
  11. Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft and The Capstone™ Spinal System with Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine - pending
Allan Martin
Allan Martin, M.D., Ph.D.
Assistant Professor

Neurological Surgery

  1. Quantitative measurement of spinal cord function in degenerative cervical myelopathy: a prospective observational longitudinal cohort study

Ryan Martin, M.D.
Assistant Professor
Departments of Neurological Surgery and Neurology  
Contact Dr. Martin at rymartin@ucdavis.edu

  1. Imaging of glial activation and risk for post-traumatic epilepsy
  2. Traumatic Brain Injury Outcomes
  3. The UCD-DGMC TBI Neural Network-Precision Medicine Paradigm for Complex Trauma
  4. A Phase 4 Randomized Clinical Trial of Andexanet alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor - pending
Kia Shahlaie, M.D., Ph.D., F.A.A.N.S
Professor

Neurological Surgery

  1. Dual frequency, dual region deep brain stimulation of the subthalamic nucleus in Parkinson’s disease
  2. Adverse Childhood Experiences and Traumatic Brain Injury
  3. Exploration of prognostic factors in traumatic intraventricular hemorrhage
  4. Incidence and treatment of cerebral venous sinus thrombosis
  5. TBI Outcome Study
  6. DBS Cognition
  7. The effect of hyperoxia in pediatric TBI
  8. PENS (A placebo-controlled efficacy in iNPH shunting (PENS) Trial -Pending
  9. TRACK-TBI - Clinical Evaluation of the i-STAT TBI Test -Pending
  10. Lidocaine infusion in glioblastoma multiforme
  11. Subthalamic nucleus activity during cognitive processing
  12. Randomized trial of CSF shunting in patients with normal pressure hydrocephalus
Jeff Vitt
Jeff Vitt, M.D.
Assistant Professor

Neurological Surgery

  1. NOVEL - Noninvasive intracanial pressure from transcranial doppler ultrasound 
Dr. Ben Waldau

Ben Waldau, M.D.
Professor
Neurological Surgery
Contact Janice Wang-Polagruto at jfwang@ucdavis.edu

  1.   Clinical Use of a Humanitarian Use Device (HUD), the Wingspan Stent System with Gateway PTA Balloon Catheter, for the Treatment of Intracranial Atherosclerotic Disease
  2.   Prospective transcranial doppler analysis of aneurysmal subarachnoid hemorrhage patients
  3.   Influence of Temozolomide-induced suppression of adult hippocampal neurogenesis on spatial learning and memory
  4.   Single institution retrospective review of delayed clip slippage after aneurysm clipping
  5.   Spatial memory after aneurysmal subarachnoid hemorrhage
  6.   Inter-observer reliability of a new grading scale to assess coiling of cerebral aneurysms
Lara Zimmermann
Lara Zimmermann, M.D.
Assistant Professor and Director, Neurocritical Care Service

Neurological Surgery

  1. CURE - Genetic and Protein Biomarkers of Post-traumatic Epilepsy to Improve Prediction of PTE: a Prospective Study in an Enriched Patient Population - DoD - Citizens United for Research in Epilepsy
  2. A Prospective Multi-Center Cohort Study of Metagenomic Deep Sequencing for Diagnosis of Acute Infectious Diseases
  3. Brain Oxygen Optimization in Severe Traumatic Brain Injury—Phase 3 (BOOST-3)
  4. The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBios4Rx)
  5. Bio-BOOST: Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial
 
Marike
Marike Zwienenberg, M.D., F.A.A.N.S.
Professor

Neurological Surgery

  1. Selection of children with severe TBI for neurosurgical intervention. External validation of a clinical guideline
  2. Predicting the outcome of children with non-accidental traumatic brain injury: Utility of the GCS versus GCS-P in children less than 3 years of age
  3. Long term outcome of moderate to severe TBI in children
  4. Limiting radiation exposure in children